PD36-07 SAFETY AND EFFICACY OF CO 2 FRACTIONAL LASER THERAPY IN WOMEN WITH VESTIBULAR PAIN

Abstract

You have accessJournal of UrologySexual Function/Dysfunction: Female (PD36)1 Apr 2020PD36-07 SAFETY AND EFFICACY OF CO2 FRACTIONAL LASER THERAPY IN WOMEN WITH VESTIBULAR PAIN Sue Goldstein, Susan Kellogg Spadt, Filippo Murina, Noel Kim, and Irwin Goldstein* Sue GoldsteinSue Goldstein More articles by this author , Susan Kellogg SpadtSusan Kellogg Spadt More articles by this author , Filippo MurinaFilippo Murina More articles by this author , Noel KimNoel Kim More articles by this author , and Irwin Goldstein*Irwin Goldstein* More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000907.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: CO2 fractional laser (MonaLisa Touch) has been used for the treatment of vaginal atrophy in menopausal women, but pain is often from the vestibule in both pre- and post-menopausal women. In this 3-site, prospective, double-blind, sham-controlled investigator-initiated pilot study, pain in the vulvar vestibule was treated using the vestibular probe. METHODS: A total of 70 subjects meeting inclusion and exclusion criteria were randomized to active or sham treatment 2:1. Changes were assessed on cotton swab test, Female Sexual Function Index (FSFI), Female Sexual Distress Score (FSDS-R), and O’Leary/Sant Voiding and Pain Indices (ICSI/ICPI). Vulvoscopic photography was performed at screening and last visit, blinded and examined by an independent reviewer, scoring 10 parameters of vulvar, vestibular, urethral meatus and vaginal health. Each arm consisted of 3 treatments (weeks 0, 4, 8) with follow-up at weeks 12 and 16. Subjects assigned to sham were crossed over to active treatment at week 12, with 3 active treatments and follow-up. RESULTS: Cotton swab test scores decreased significantly after active treatment at week 4 (mean change from baseline = -0.64; 95% CI [-0.79, -0.50]) through week 16 (mean change = -1.31; 95% CI [-1.46, -1.16]) compared to baseline, suggesting decreased pain. FSFI pain domain scores increased significantly from baseline at week 12 (mean change = 0.925; 95% CI [0.10, 1.75]) and week 16 (mean change = 1.22; 95% CI [0.40, 2.05]), indicating improved function. FSFI total scores also increased significantly at weeks 12 and 16 (mean change = 6.24; 95% CI [2.64, 9.85] and 4.96; 95% CI [1.36, 8.57], respectively). FSDS-R scores decreased significantly at weeks 12 and 16 (mean change = -5.84; 95% CI [-8.80, -2.87] and -9.15; 95% CI [-12.11, -6.18], respectively). ICSI scores decreased significantly from baseline at weeks 12 and 16 (mean = -0.91; 95% CI [-1.65, -0.18] and -0.754; 95% CI [-1.49, -0.02], respectively) while ICPI scores decreased significantly at week 16 (mean = -0.99; 95% CI [-1.63, -0.34]). Changes based on vulvoscopic photographs revealed reduced pallor, reduced erythema, and increased moisture. No SAE occurred. CONCLUSIONS: These data suggest that CO2 fractional laser therapy in women with vestibular pain improves measures of pain, decreases pain and bother symptoms of voiding, and improves tissue health of the vulva, vestibule, urethral meatus and vagina. Source of Funding: Unfunded © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e725-e725 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sue Goldstein More articles by this author Susan Kellogg Spadt More articles by this author Filippo Murina More articles by this author Noel Kim More articles by this author Irwin Goldstein* More articles by this author Expand All Advertisement PDF downloadLoading ...